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Completed

NCT Number: NCT05249985

Protein Supplementation and Neuromuscular Electrical Stimulation in Persons With SCI

The aim of this pilot study is to explore how body composition, circulating markers of metabolic health and skin integrity in persons with a spinal cord injury (SCI) are affected by 12 weeks of quadriceps neuromuscular electrical stimulation (NMES) resistance training. The novel element of this study is that one group will be given additional daily protein supplementation in addition to the NMES training (treatment group), whereas the other group will only perform the NMES training (control group). The investigators hypothesise that NMES in combination with protein results in larger improvements in the aforementioned outcomes compared with NMES alone.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, Leicestershire, LE113TU, United Kingdom

About this study

A spinal cord injury (SCI) is a debilitating condition, with paralysis below the lesion level as one of the main hallmarks. As a result of paralysis, together with decreased levels of physical activity and impairment-specific co-morbidities such as autonomic dysfunction, persons with SCI have a markedly reduced muscle mass. Being the major site for glucose disposal, skeletal muscle is key for the maintenance of metabolic health, while it also helps with weight management by contributing to energy expenditure at rest. As such, effective strategies to restore muscle mass in persons with SCI are warranted and can have a significant impact on metabolic health and chronic disease risk in this population.

While resistance training is widely recognised as an effective intervention to increase muscle mass in able-bodied individuals, paralysis in the lower limbs of persons with SCI precludes the use of traditional resistance training in this population. NMES has been developed to overcome this barrier and allows persons with SCI to engage in resistance exercise. Notwithstanding the evidence supporting the use of NMES on its own, combined interventions may further enhance its potential to improve health and physical function. Indeed, in the more widely studied population of older adults, that is also at risk for sarcopenia (loss of skeletal muscle mass and strength), increasing daily protein intake enhances the efficacy of resistance training to increase muscle mass.

The primary objective of this study is to determine the impact of a 12-week intervention of NMES in combination with protein supplementation when compared with NMES alone on fat free mass in the legs. Secondary objectives are to investigate the impact of the intervention on 1) markers of cardiometabolic health, namely glucose tolerance and fasting plasma lipid concentrations, 2) resting metabolic rate, and 3) skin blood flow at the level of the sacrum in response to experimental pressure. Outcomes related to tertiary objectives include perceived quality of life, neuropathic pain, body image, sleep quality and spasms; as well as free-living energy balance, physical activity and feasibility outcomes related to recruitment, adherence and participant' experiences with the intervention. It is hypothesised that NMES in combination with protein results in larger improvements in the aforementioned outcomes compared with NMES alone.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Motor complete spinal cord injury
  • Time since injury injury >1 year

Exclusion criteria

  • Spinal cord injury below T10 vertebrae
  • Habitual protein intake exceeding 2g / kg body mass / day
  • Having used NMES resistance training once or more per week in the last six months
  • Lactose intolerant
  • Any disease or medication that means the participant should not exercise
  • Participation in a study involving ionising radiation in the previous 12 months

Treatment and study plan

NMES

Device

Participants will undergo 12 weeks of neuromuscular electrical stimulation- (NMES) based resistance training on the quadriceps.

Protein

Dietary Supplement

Participants will consume a daily protein supplement

Primary outcomes

  1. Change in bone mineral density

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Dual x-ray absorptiometry

  2. Change in lean soft tissue mass

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Dual x-ray absorptiometry

  3. Change in fat mass

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Dual x-ray absorptiometry

Secondary outcomes

  1. Change in glucose tolerance

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Oral glucose tolerance test

  2. Change in insulin resistance

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Oral glucose tolerance test

  3. Change in fasting plasma lipid concentrations

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Resting blood sample

  4. Change in fasting circulating C-reactive protein

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Resting blood sample

  5. Change in sacral skin blood flow

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Doppler flowmetry

  6. Change in resting metabolic rate

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Expired air analysis

Other outcomes

  1. Change in blood pressure

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Automatic blood pressure cuff

  2. Change in daily energy intake

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    3 day food diary

  3. Change in physical activity

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Wrist-worn accelerometer

  4. Change in physical activity

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Leisure time physical activity questionnaire

  5. Change in sleep efficiency and duration

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Wrist-worn accelerometer

  6. Change in sleep quality

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Sleep Quality Scale (available answers include: rarely, sometimes, often, almost always)

  7. Change in muscle spasticity

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    The Spinal Cord Injury Spasticity Evaluation Tool

  8. Change in mental health

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    5-item Mental Health Inventory

  9. Change in neuropathic pain

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Neuropathic Pain Questionnaire

  10. Change in body image

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Body Image Satisfaction Questionnaire

  11. Change in skinfold thickness

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Measured in millimetre

  12. Height

    Time frame: Pre-intervention only

    Measured in meters

  13. Change in waist and hip circumference

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Measured in centimeters to provide a waist-to-hip ratio

  14. Change in body weight

    Time frame: Pre-intervention (baseline) and at 1 week post-12 week intervention

    Measured in kilograms

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Collaborators

  • Danone Nutricia
  • McMaster University

Registry information

Official study title

Effects of Protein Supplementation and Neuromuscular Electrical Stimulation on Fat-free Mass in Persons With Motor Complete Spinal Cord Injury: a Pilot Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2022
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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